DIRECT-SAFE: A Randomized Controlled Trial of DIRECT Endovascular Clot Retrieval versus Standard Bridging Therapy

作者：Peter Mitchell, Bernard Yan, Leonid Churilov, Richard Dowling, Steven Bush, Thang Huy Nguyen, Bruce Campbell, Geoffrey A. Donnan, Zhongrong Miao, Stephen M. Davis, on Behalf of the DIRECT-SAFE Investigators · 发表于：Journal of Stroke · 年份：2022 · DOI：10.5853/jos.2021.03475 · 被引用次数：38 · 研究领域：Acute Ischemic Stroke Management、Cerebrovascular and Carotid Artery Diseases、Stroke Rehabilitation and Recovery

BACKGROUND AND PURPOSE: The benefit regarding co-treatment with intravenous (IV) thrombolysis before mechanical thrombectomy in acute ischemic stroke with large vessel occlusion remains unclear. To test the hypothesis that clinical outcome of ischemic stroke patients with intracranial internal carotid artery, middle cerebral artery or basilar artery occlusion treated with direct endovascular thrombectomy within 4.5 hours will be non-inferior compared with that of standard bridging IV thrombolysis followed by endovascular thrombectomy. METHODS: To randomize 780 patients 1:1 to direct thrombectomy or bridging IV thrombolysis with thrombectomy. An international-multicenter prospective randomized open label blinded endpoint trial (PROBE) (ClincalTrials.gov identifier: NCT03494920). RESULTS: Primary endpoint is functional independence defined as modified Rankin Scale (mRS) 0-2 or return to baseline at 90 days. Secondary end points include ordinal mRS analysis, good angiographic reperfusion (modified Thrombolysis in Cerebral Infarction score [mTICI] 2b-3), safety endpoints include symptomatic intracerebral hemorrhage and death. CONCLUSION: s DIRECT-SAFE will provide unique information regarding the impact of direct thrombectomy in patients with large vessel occlusion, including patients with basilar artery occlusion, with comparison across different ethnic groups.